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NCT03013751 · ClinicalTrials.gov registry record · Phase 3
A Extension Study of Udenafil in Adolescents
A Phase 3 study of Functional Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT03013751: Completed Phase 3 study of Functional Single Ventricle Heart Disease, sponsored by Mezzion Pharma Co..
NCT03013751 is a Phase 3 study of Functional Single Ventricle Heart Disease that has completed, run by Mezzion Pharma Co.. The registered enrollment target is 301 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03013751, a Phase 3 study of Functional Single Ventricle Heart Disease, has completed, sponsored by Mezzion Pharma Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
Primary Outcome
Summary of Treatment Emergent Adverse Events
Conditions Studied
Interventions
- DRUG Udenafil
Study Locations (20)
California
- Cedars/Sinai Heart Institute - Los Angeles
- Rady Children's Hospital - San Diego
Missouri
- Children's Mercy Hospital Kansas City - Kansas City
- Washington University St. Louis/St.Louis Children's Hospital - St Louis
Arizona
- Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours Cardiac Center/Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Johns Hopkins All Children's Heart Institute - St. Petersburg
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
What the finished NCT03013751 record still lists
NCT03013751 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Functional Single Ventricle Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Udenafil is the first listed.
NCT03013751 names 20 study sites across 18 states, led by California, Missouri, Arizona.
Frequently Asked Questions
What is clinical trial NCT03013751 about?
NCT03013751 is a clinical study titled "A Extension Study of Udenafil in Adolescents". This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
What is the current status of trial NCT03013751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2017-02-06. Estimated completion is 2022-12-20.
What conditions does trial NCT03013751 study?
This clinical trial studies the following conditions: Functional Single Ventricle Heart Disease.
What interventions are being tested in trial NCT03013751?
The interventions under investigation include: Udenafil (DRUG).
Who is sponsoring clinical trial NCT03013751?
This trial is sponsored by Mezzion Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03013751 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03013751's enrollment target sits among peer trials
301 1121st of 2000 higher than 879 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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